SPOKE trial

A common mechanism of injury in the Netherlands is when a child gets stuck with his or her foot between te spokes of a riding bicycle. The best wound treatment of these spoke-injuries is unclear, and especially with bandage renewal and evaluation of the wound, patients can have significant pain.

In this study we try to investigate wether treatment with a biodressing impregnated with polyhexamethylene biguanide gives less pain than the usual treatment wich is a dressing with ointment.

The study design is a randomised controlled trial, in wich the two treatments are compared: standard treatment with wound-dressing with ointment to prevent adhesion to the wound compared to biodressing impregnated with polyhexamethylene biguanide.

Study population will exist of children from 4-18 years with a spoke injury of the lower extremity.



Primary outcome is pain, as measured with a Faces Pain Scale-revised and a FLACC score. Secondary outcomes are duration of treatment and wound infection.

wound treatment of foot and ankle injuries in children after a foot becomes caught in the spokes of a riding bicycle can be treated with less pain when using a biodressing impregnated with polyhexamethylene instead of the usual ointment gauze bandage

first contact at emergency department, [day0]

appointments with treating MD and 'gipsverbandmeester'(cast master) untill wound has healed

wound treatment with biodressing impregnated with polyhexamethylene